CIRARA in Large Hemispheric Infarction Analyzing Modified Rankin Scale (mRS) and Mortality (CHARM) "CHARM"

Not yet recruiting

Phase 3 Results N/A

Trial Description

This study evaluates the use of the investigational drug CIRARA versus placebo in patients with a large hemispheric infarction.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of participants with improvement in functional outcome at 90 days assessed via the modified Rankin Scale Change from baseline at 90 days No
Secondary Proportion of participants with improvement in overall survival at 90 days Change from baseline at 90 days No
Secondary Proportion of participants with a reduction in midline shift at 72 hours assessed via non-contrast computed tomography Change from baseline at 72 hours No
Secondary Safety of CIRARA via collection of adverse events and serious adverse events Change from baseline through 15 days Yes

Sponsors